“There is the old adage that you cannot test quality into a product. By the same token, you cannot manage service and quality into a CDMO,” says Roger Graben, biopharma industry veteran and president of Vitruvias Therapeutics. But he’s got some sage advice on how to select your service provider, and work best within those limitations.
The ongoing Brexit negotiations between the British Parliament and the EU has left pharma supply chain managers scrambling for cover. As recently as October 2018, the probability of a no-deal scenario was low and it made little sense to invest in or commit to alternate plans, but this changed when Parliament rejected Prime Minister Theresa May's deal in December. The politics are not as important to business as the conclusion: The best way to mitigate disruption is to more heavily weigh finding alternate ex-U.K. suppliers versus waiting it out. Negotiating deals and supply agreements takes time, as does the logistics of tech transfer and moving materials. So risk management, timing, and terms are key success factors.
ISR data, collected for the purpose of improving our understanding of the much-anticipated bioprocessing capacity crunch, reveals that it is not a matter of if or when a capacity crunch will impact the biopharmaceutical industry; instead, it’s a question of who, or which types of drug innovators, will be impacted.
A validation master plan (VMP) outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. Master plans are written to assist an organization with validation strategies or to provide control over a specific process.
Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.
This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.
In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.
Choosing an offsite storage facility means asking the right questions, to determine if the storage provider has the appropriate risk mitigation infra-structure in place, beginning with a realistic threat assessment for the location.
Sponsors do have their own CTMS or EDC systems and sites log into them to enter clinical data for a given sponsor or trial. But none of these systems belong to the site and none are devoted to the business operations of the site across all studies.
Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them.
In the shift to single-use technology, there is both an opportunity and an obligation to understand the sustainability impacts of this development.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
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The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But you need to consider your long-term needs.
If you have decided to add capacity in-house, you need to consider which location enables you to meet demand. Having knowledge of the local operating environment and regulatory considerations is vital.
It is critical the experts creating a drug product’s formulation are aware of any reactions that can occur between an API and a tablet’s excipients.
With today’s complex manufacturing systems and processes, can a manufacturer afford to not have a centralized automation platform?
The failure of drug compounds in mid- to late-stage development is far more common than anyone would like it to be. Only about 30% of compounds successfully transition from Phase II to Phase III.